Femoral neck support structure, system, and method of use

ABSTRACT

A method of reinforcing a femoral neck comprises creating a bore proximate to at least one of a Ward&#39;s triangle and a greater trochanter, creating at least one cavity in a cancellous bone region of the femoral neck, inserting a substantially collapsed support structure through the bore and into the at least one cavity, expanding the support structure, and allowing at least a portion of the load from the femoral neck bone to be transferred to the support structure. The support structure compresses at least a portion of the cancellous bone upon expansion. A cavity created by the expansion is adapted to receive a filler material such as, but not limited to, bone cement.

PRIORITY AND CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 13/784,948 filed Mar. 5, 2013, which is divisional of, andclaims the benefit of U.S. patent application Ser. No. 12/259,929 filedOct. 28, 2008, which itself claims the benefit of Provisional U.S.patent application Ser. No. 60/983,882 filed Oct. 30, 2007. The detailsof application Ser. Nos. 13/784,948, 12/259,929 and 60/983,882 areincorporated by reference into the present application in their entiretyand for all proper purposes.

FIELD OF THE INVENTION

Aspects of the present invention relate generally to medical devices. Inparticular, but not by way of limitation, aspects of the presentinvention relate to femoral neck support devices, systems, and methodsfor operating the same.

BACKGROUND OF THE INVENTION

Bone fractures within the hip joint can cause debilitating andlife-threatening conditions. Statistics show that 50% of people over 50years of age who suffer a fracture in a hip joint bone die within thefirst year. One area of the hip that often fractures is the femoralneck. The femoral neck is the portion of the femur which integrates thebody of the femur extending from the knee joint, to the femoral head,which fits within the socket of the hip joint (Acetabulum).

The femoral neck is especially prone to fractures in persons sufferingfrom osteoporosis, where bone density is reduced. Further conditions,such as, but not limited to, diseased trabeculae in the Ward's triangleregion of the femoral neck may also increase the risk of femoral neckfractures. Common approaches to reducing femoral neck fractures includeaugmenting the strength of the femoral neck by increasing bone density.

One way bone density is increased in the femoral neck is through the useof pharmaceuticals. However, relatively minimal increases in femoralneck bone density have been attributed to pharmaceutical treatments. Forexample, one study shows an increase in femoral neck bone mass densityof only about six percent due to pharmaceutical use. See Uri A.Liberman, M. D., Ph.D., et al., Effect of Oral Alendronate on BoneMineral Density and the Incidence of Fractures in PostmenopausalOsteoporosis, The New England Journal of Medicine, Nov. 30, 1995. Thisincrease is at the upper end of bone mass density increases, as otherstudies show significantly less increase in femoral neck bone massdensity due to pharmaceutical use. Additionally, the use ofpharmaceuticals can have serious side effects such as chest pain,difficult or painful swallowing, hot flashes, joint pain, blood clots,and ulcers in the stomach or esophagus.

General suppression of hip fractures through the use of medical deviceshas also been mentioned in the prior art. For example, U.S. Pat. No.7,261,720 ('720) describes a balloon embodiment adapted to support theupper femoral area. However, the balloon embodiment described in the'720 patent does not provide adequate support and reinforcement for thefemoral neck.

SUMMARY OF THE INVENTION

Exemplary embodiments of the present invention that are shown in thedrawings are summarized below. These and other embodiments are morefully described in the Detailed Description section. It is to beunderstood, however, that there is no intention to limit the inventionto the forms described in this Summary of the Invention or in theDetailed Description. One skilled in the art can recognize that thereare numerous modifications, equivalents and alternative constructionsthat fall within the spirit and scope of the invention as expressed inthe claims.

In accordance with one embodiment a device for reinforcing a femoralneck bone, the femoral neck bone including a cortical bone region and acancellous bone region, comprises a support structure deployable from afirst substantially collapsed position to a second substantiallyexpanded position, the support structure adapted to displace at least aportion of the cancellous bone region and wherein when deployed in thesecond substantially expanded position, the support structurestructurally interacts with at least a portion of the cortical boneregion.

In accordance with another embodiment, a method of reinforcing a femoralneck comprises creating a bore proximate to at least one of a Ward'striangle and a greater trochanter, creating at least one cavity in acancellous bone region of the femoral neck, inserting a substantiallycollapsed support structure through the bore and into the at least onecavity, expanding the support structure, and allowing at least a portionof the load from the femoral neck bone to be transferred to the supportstructure.

These and other embodiments are described in further detail herein.

BRIEF DESCRIPTION OF THE DRAWINGS

Various objects and advantages and a more complete understanding of thepresent invention are apparent and more readily appreciated by referenceto the following Detailed Description and to the appended claims whentaken in conjunction with the accompanying Drawings, wherein:

FIG. 1A is a side-view of an expanded femoral neck support structurewithin a femoral neck;

FIG. 1B is a side-view of one embodiment of a collapsed femoral necksupport structure;

FIG. 2A is a side view of one example of a femoral body, neck, and head;

FIG. 2B is a cross-sectional view of the femoral neck having an expandedsupport structure placed therein along line A-A of FIG. 1A;

FIG. 3A is a side view of an actuation device having a cut-away portionnear the actuator head, and a close-up side view of an actuator headcut-away portion;

FIG. 3B is a side view of an actuation device and a support structurewithin a cross-section of a femoral head and neck;

FIG. 3C is a side view of a support structure section showing how atrigger mechanism motion may be applied;

FIG. 3D is a side view of an actuation device head cut-away portionshowing two lumens;

FIGS. 4-15 are various embodiments of a femoral neck support structureconstructed in accordance with aspects of the present invention;

FIG. 16A are side views of a Ward's triangle bore, an actuation device,a pair of actuators, and a support structure according to one embodimentof a device constructed in accordance with aspects of the presentinvention;

FIG. 16B shows a plurality of views of an accordion-styled supportstructure according to one embodiment of a device constructed inaccordance with aspects of the present invention;

FIG. 16C is a side view of a Ward's triangle bore and cavity havingthree support structures and filler material located therein;

FIG. 17A is a side view of a pair of rotationally deployable supportstructure sections according to one embodiment of a device constructedin accordance with aspects of the present invention;

FIG. 17B is a side view of a telescopically deployable support structureaccording to one embodiment of a device constructed in accordance withaspects of the present invention;

FIG. 18 are side views of a femoral neck support structure adapted to bedeployed from a greater trochanter bore according to one embodiment of adevice constructed in accordance with aspects of the present invention;

FIGS. 19A-19B are side views of a device comprising a sheath and asupport structure according to one embodiment of a device constructed inaccordance with aspects of the present invention;

FIG. 20 is a cross sectional view of another embodiment of a femoralneck support structure;

FIG. 21A is a side-view of another embodiment of a femoral neck supportstructure and a cross-section of a femoral head, neck and body portions;

FIG. 21B is a top view of a femoral neck support structure placementwithin a femoral head;

FIG. 22 is one embodiment of a method of reinforcing a femoral neck;

FIG. 23 is another embodiment of a method of reinforcing a femoral neck;

FIG. 24 is yet another embodiment of a method of reinforcing a femoralneck;

FIG. 25A is a top view of a femoral neck with an anterior Ward'striangle bore and having a femoral neck support structure locatedtherein; and

FIG. 25B is a side view of a femoral neck with an anterior Ward'striangle bore.

DETAILED DESCRIPTION

Referring now to the drawings, where like or similar elements aredesignated with identical reference numerals throughout the severalviews where appropriate, and referring in particular to FIGS. 1A-2B, adevice 100 for reinforcing a femoral neck 102 bone is shown anddescribed. As shown in FIG. 2A, the femoral neck 202 is a portion of thefemur 204 which resides between the greater trochanter 206 and thefemoral head 205, connecting the femoral body 203 to the femoral head205, which rests in the hip joint. The device 100 is adapted to beplaced inside the femoral neck 202 bone, thereby reinforcing the femoralneck 202 from the inside.

In one embodiment, the device 100 is comprised of a support structure110, as shown in FIG. 1A. One support structure 110 may be deployablefrom a first substantially collapsed position, as shown in FIG. 1B, to asecond substantially expanded position, as shown in FIG. 1A. In oneembodiment, the collapsed position is used so the structure 110 may beinserted into the femoral neck 102. For example, the collapsed supportstructure 110 may enter the femoral neck 102 through at least one of aWard's triangle bore 120′ and a greater trochanter bore 120″ andsubsequently expand into the femoral neck 102.

In order to expand, one embodiment may be comprised of a stent 112 and aballoon 114. The expansion of the structure 110 into the femoral neck102 may be actuated by expanding the balloon 114 from a locationproximate a bore 120′, 120″ into an internal femoral neck 102 region.Other expansion techniques known in the art not using balloons are alsocontemplated. For example, the stent 112 may be actuated to expand fromthe collapsed position to the expanded position by applying at least oneof a lateral force 111 and a longitudinal force 113 onto the structure110, as shown in FIG. 1B. Such forces 111, 113 may be used on deviceswhich are not comprised of a balloon 114. However, similar forces mayalso be used on devices having one or more balloons 114. Furthermore,some embodiments may be comprised of one or more stents 112 or balloons114. Embodiments are further contemplated comprising one or more devices100.

As shown in FIG. 1A, a femur 104 may be comprised of cortical bone 107and cancellous bone 108. In an osteoporotic patient, or in patientshaving other ailments, the cancellous bone 108 may have a low bone massdensity or may otherwise be relatively malleable bone matter as comparedto portions of the cortical bone 107 which may be healthier, more rigidbone matter. One structure 110 is adapted to expand within thecancellous bone 108. In one embodiment, upon expansion of the supportstructure 110 into the femoral neck 202, a cavity 209 is created, asshown in FIG. 2B. In one embodiment, the cavity 209 is created throughthe expansion of the structure 210 itself. However, in otherembodiments, the cavity 209 may be created prior to expansion of thestructure 210. For example, a cavity may be drilled, tapped, or punchedwithin the cancellous bone 208 and a collapsed structure 210 may beplaced into the cavity 209 and subsequently expanded. In one embodiment,such as an embodiment where the structure 210 creates the cavity 209,the cancellous bone 208 may be compressed. Cancellous 208 bone may alsobe removed from the femoral neck 202 through a drill or otherwise. Asshown in FIG. 2B, the cancellous bone 208 may be compressed between thesupport structure 210 and the cortical bone 207. In one embodiment, theballoon 214 may expand and compress the cancellous bone 208 and thestent 212 may subsequently be inserted into the cavity 209 created bythe balloon 214 and expanded.

When deployed in the second substantially expanded position, as shown inFIGS. 1A and 2B, support structure 210 may be further adapted tointeract with the cortical bone 207. In one embodiment, for example, oneor more staples 215, or other similar mechanisms, may be used to couplethe structure 210 to the cortical bone 207 or the compressed cancellousbone 208. However, the structure 210 may interact with the cortical bone207 in one or more other manners as well. For example, as shown in FIGS.1A & 2B, one embodiment may be configured to have an outer surface shapewhich generally forms to an inner surface of the cortical bone 107,allowing the support structure to fit snugly within the healthy corticalbone 207. Adapting the shape of the structure 110 to resemble the shapeof the cortical bone 107 within the femoral neck 202 enables interactionbetween the structure 110 and the cortical bone 107. Interaction occurswhen an external load such as, but not limited to, a peak gait load 135or a lateral fall load 130, is applied to the femoral neck 102. In sucha case, the load is transferred from the cortical bone 107 to thestructure 110, allowing the structure 110 to reinforce the femoral neck202. In at least one embodiment, load may be transferred to thestructure 110 through contact between the cortical bone 107 and thestructure, while in other embodiments, interaction between the corticalbone 107 and structure 110 may occur through the compressed cancellousbone 108 or bone cement.

It should be noted that the Ward's triangle bore 120′ shown in FIG. 1Aand elsewhere, may comprise an anterior Ward's triangle bore 2520′,located in the femoral neck 2502, as shown in FIGS. 25A and 25B. Allembodiments discussed herein may enter through the anterior Ward'striangle bore 2520′. One such embodiment may comprise a supportstructure 2510 having a portion comprising one or more bores 2527.Through at least one of the bores 2527, a support structure section 2729may be released into the cancellous bone 2508. Upon being released fromthe bore 2527, the support structure section 2729 may expand.Furthermore, filler material 2595 may be released from the bore 2527into the cancellous bone 2508. Filler material 2595 in one embodimentmay enter directly into the cancellous bone 2508 or the filler material2595 may enter into the cancellous bone 2508 along with a supportstructure section 2529, as shown in FIG. 25A.

Referring to FIGS. 3A-3C, one embodiment of a femoral neck 302 supportstructure 310 may also include an actuation device 340. Actuation device340 is adapted to deliver the support structure 310 to the femoral neck302. For example, actuation device 340 may be comprised of a tubeadapted to substantially enclose a compressed support structure 310. Theactuation device 340 may be steerable, enabling an actuation device head342 to be positioned proximate the femoral neck bore 320. In someembodiments, the actuation device head 342 may also be adapted to bepositioned in the bore 320, the cortical bone 307, or the cancellousbone 308.

Once the actuation device head 342 is in the correct position, thesupport structure 310 may be deployed. Actuation device 340 may deploythe support structure 310 through a trigger mechanism 344. The triggermechanism 344 may be adapted to steerably release separate supportstructure sections into separate areas of the femoral neck 302. Forexample, as shown in FIGS. 3A & 3B, support structure 310 may becomprised of a first section 346, a second section 347, and a thirdsection 348. Upon actuating the trigger mechanism 344, the first,second, and third sections 346, 347, 348 are released from the tube intoseparate cancellous bone 308 areas. The trigger mechanism may be adaptedto receive one or more pushing, pulling, or twisting motions, in orderto actuate the release of the support structure 310.

A first section 346 may be designed to be released from the actuationdevice 340 and bend towards the greater trochanter 306 and a thirdsection 348 may be designed to bend towards the femoral head 305.Structure sections 346, 348 may be adapted to bend in a specificdirection by coupling an elastomeric band having a first length to oneside of the section and coupling an elastomeric band having a longersecond length to the opposing side of the section, thereby causing thesection to bend towards the side having the shorter elastomeric band.Bending individual support structure sections 346, 347, 348 to a properinternal femoral neck 302 location may also occur through a motionapplied at the trigger mechanism 344. For example, as shown in FIG. 3C,a pulling motion applied at the trigger mechanism 344 may be transferredto a side 349 of the first structure section 346, allowing the section346 to bend towards the pulled side 349.

Referring to FIGS. 4-15, various embodiments of femoral neck supportstructures 110 comprising various stent 112 configurations are shown anddescribed. It should be understood that the support structures describedherein are not meant to be limited to the various configurations shownin FIGS. 4-15 or any other figure. FIGS. 4 & 15 comprise exampleembodiments of a truss or a strut support structure 410 and 1510. FIG. 5comprises one embodiment of a mesh support structure 510 and FIGS. 6A,6B and 7 comprise embodiments of a tubular support structure 610 and710, while FIGS. 8, 10, and 11 comprise embodiments of biasing devicesupport structures such as spring support structures 810, 1010 and 1110.FIGS. 9 and 12 comprise embodiments of coiled or spring structures 910and 1210. While FIGS. 13 & 14 show expanded support structures 1310 and1410 adapted to receive filler material 1395 and 1495 (e.g. bonecement), each of the structures in FIGS. 4-15 may comprise expandablesupport structures adapted to receive filler material 1395 and 1495.Furthermore, it is to be appreciated that each of the structures inFIGS. 4-15 may, in some embodiments, be similar to the structuredescribed in FIGS. 1A-1B.

The stents 112 described herein may be comprised of 316L stainless steelor nickel titanium alloy. However, other material known in the art mayalso be used. For example, it is contemplated that a polymeric materialmay be used for the stents 112 and/or the balloons 114 in someembodiments.

As shown in FIGS. 6A & 6B, one embodiment may be comprised of one ormore unitary devices 600. Unitary device 600 may be comprised of anintegrated head portion 680, distal neck portion 682, and proximal neckportion 684. Unitary device 600 may further be compressible. Forexample, unitary device 600 may be a substantially hollow device havinga generally hourglass shape comprised of a substantially elastomeric ormalleable material. Upon expansion, the unitary device 600 may beadapted to be subsequently filled with filler material.

Looking now at FIGS. 16A-16C, shown is the insertion of one or morecompressed accordion devices 1650 into the Ward's triangle bore 1620′and subsequent expansion of the device 1650 in the cavity 1609. Oneaccordion device 1650 may expand upon being inserted through the Ward'striangle bore 1620′ upon the use of a pair of actuators 1649 as shown inFIG. 16A. Each actuator 1649 may be adapted to remove the accordiondevice 1650 away from the actuation device head 1642, placing the deviceinto the cavity 1609. Once in the cavity 1609, a first actuator 1649′may drive one end of the device 1650 in a first direction and a secondactuator 1649″ may drive an opposing end of the device 1650 in a seconddirection. The second direction may generally oppose the firstdirection. These motions may happen sequentially or concurrently.However, embodiments are contemplated which are adapted to use more orless than two actuators 1649 or expand in more than two directions.Furthermore, as shown in FIG. 16C, more than one structure 1610 may beplaced within the cavity 1609. Filler material may also be used in thecavity 1609, and in one embodiment, the filler material 1695 may holdthe one or more structures 1610 in the proper position within the cavity1609. As shown in FIGS. 16A-16C, it is also contemplated that oneembodiment may interact with bone cement or other filler material 2095instead of the cortical bone 107 or cancellous bone 108 shown in FIG.1A.

With reference to FIG. 17A, additional devices adapted to expand with orwithout the actuators 1649 may comprise telescoping support structures1710, as shown in FIG. 17B, and rotationally deployable devices 1760, asshown in FIG. 17A. The telescoping and rotational devices 1710 and 1760may be adapted to deploy in a single direction or bi-directionally fromeither the greater trochanter bore 120″ or the Ward's triangle bore120′. An additional embodiment adapted to expand bi-directionally from agreater trochanter bore 120″ insertion location is shown in FIG. 18. Asshown, upon applying a single pulling motion to an actuator 1849, thestructure 1810 expands bi-directionally. Other devices are alsocontemplated.

Focusing now on FIGS. 19A-19B, shown is a device 1900 comprising asheath 1970 and a support structure 1910. As shown in FIG. 19A, thesheath 1970 in one embodiment is adapted to substantially surround acompressed support structure 1910. As shown in FIG. 19B, the sheath 1970is adapted to subsequently be removed to expose the support structure1910. Upon removing the sheath 1970, for example, by sliding the sheath1970 in a direction substantially parallel to a structure longitudinalaxis (such as, but not limited to, the longitudinal axis 417 shown inFIG. 4), support structure 1910 is adapted to expand. Support structure1910 may be adapted to laterally expand bi-directionally upon removal ofthe sheath 1970, although the structure may also be adapted to expanduni-directionally or in more than one or two directions.

For example, as shown in FIG. 19B, the support structure 1910 may becomprised of a biasing device such as, but not limited to, one or morecompression springs 1919 which, when the sheath 1970 is removed, expanda stent 1914. Other designs of compressed or coiled support structures1910 may also be used with the sheath 1970. Furthermore, it iscontemplated that an accordion device 1650 may be used with the sheath1970. In one embodiment, the sheath 1970 may be a portion of theactuation device 340, shown and described in FIGS. 3A-3C.

FIG. 20 comprises a structure 2010 similar in many respects to thestructure 210 shown in FIG. 2B. It is to be appreciated that anembodiment of a support structure 2010 is contemplated to have variousmaterial properties such as, but not limited to, viscoelasticproperties. Furthermore, one embodiment may comprise a structure 2010having a time dependent or a temperature dependent property. Forexample, a stent or a filler material 2095 used within a cavity (similarto the cavity 209 shown in FIG. 2B) may become rigid after a certainperiod of time, or may harden within the cavity upon reaching a certaintemperature or upon the application of a certain wavelength of light.Filler material 2095 is also contemplated to comprise a gelatinousmaterial in one embodiment or may comprise a bone growth chemicalregulator such as, but not limited to, hyaluronic acid andglycosaminoglycan. Bone growth chemical regulators may be growth factorsadapted to locally promote and increase bone density and/or ingrowthinto the structure 2010. Many growth factors may stimulate an overallpositive level of bone formation in vivo, such as IGF-I, IGF BP-3 andthe TGF-Beta family, among others. Other methods and embodiments adaptedto increase bone density are contemplated such as including osteoblastcells from an allograft or autograft. Locally promoting bone growth maylead to higher bone density than can be obtained through the use ofsystemic pharmaceuticals. Filler material 2095 may also be comprised ofmaterial such as, but not limited to, cement, glue, adhesive, and foam,or a combination of one or more of these or other materials. Together,the support structure and the filler material are adapted to support andstrengthen the femoral neck 2002.

Shown in FIG. 20 is a femoral neck support system 2090. A femoral necksupport system may be comprised of the support structure 2010. Thesupport structure 2010 used within the support system 2090 is similar tothe support structures described elsewhere herein. For example, thesupport structure 2010 may be comprised of at least one balloon 2014 ormay be comprised of at least one spring, similar to the plurality ofsprings shown in FIG. 19B. Like the previously described supportstructures 2010, the femoral neck support system 2090 defines at leastone internal cavity. For example, as shown in FIG. 2B, the expandedballoon 214 defines an internal space comprising the cavity 209.Furthermore, the support structure 2010 may be comprised of internalsupport beams 2092 and external support beams 2094. The internal supportbeams 2092 may extend through the cavity while the external supportbeams 2094 may extend along a cavity edge. Although shown as beingperpendicularly aligned in FIG. 20, it is contemplated that someinternal and external support beams are not perpendicularly aligned. Thefiller material 2095 is adapted to fill the space between opposingexternal support beams 2094 and around the internal support beams 2092.

The actuation device 340 shown in FIGS. 3A-3B may also be adapted todeliver filler material 395 to an internal cavity. For example, as shownin FIG. 3D the actuation device 340 may comprise at least one lumen 351adapted to deliver the filler material 395 to the cavity and at leastone other lumen 351 adapted to deliver the structure 310. Lumens 351having other support system components such as, but not limited to, thesheath 1970 shown in FIGS. 19A & 19B, are also contemplated.

In viewing FIGS. 1A, 4, and 20, embodiments of a support structure 110,410, and 2010 having filler material 2095 may be oriented along alongitudinal axis 417 while being subjected to a maximum peak gait load135 or a lateral fall load 130. One lateral fall load 130 may also bereferred to as a first load and a one peak gait load 135 may also bereferred to as a second load. In one embodiment, the filler material2095 and structure 410 may be adapted to receive a maximum peak gaitload 135 of about 7 kN before plastic deformation or structural failureoccurs. One peak gait load 135 may be applied generally parallel to thelongitudinal axis 417. However, it is understood that the loads 130 and135 discussed herein and applied to the femoral neck 102, supportstructure 410, 110, and 2010, and filler material 2095 may vary overtime, direction, and location. Therefore the loads 130 and 135 in FIG.1A are only generally representative of peak gait and lateral fall loadson the device 100. For example, one peak gait load 135 may be appliedthirteen degrees off a vertical plane and may be centered at a differentlocation on the femoral head 105 than what is shown in FIG. 1A.Likewise, it is to be appreciated that the lateral fall load 130direction may be applied 30 degrees off a horizontal plane and adifferent location than what is shown in FIG. 1A. In one embodiment, amaximum lateral fall load 130 that one support structure 2010, 410, 110and filler material 2095 may be adapted to receive without plasticdeformation or structural failure is about 12 kN. The lateral fall load130 may also be applied generally perpendicular to the longitudinal axis417 of the support structure 410.

As shown in FIGS. 21A-21B, one further embodiment may be comprised of atleast one guide wire 2197 and a plurality of support blocks 2199. Thesupport blocks 2199 and guide wires 2197 may be delivered to the femoralneck 2102 through the actuation device 340 described in FIGS. 3A-3D. Inone embodiment, the guide wires 2197 may be inserted into one or morecavities created within the femoral neck 2102. For example, a balloon orother device may create a first cavity 2109′, a second cavity 2109″ anda third cavity 2109′″. Upon insertion of the guide wires 2197 to thecavities 2109′, 2109″, and 2109′, the support blocks 2199 may bedelivered along the guide wires 2199 into the cavities. Each supportblock 2199 may be adapted to couple to each adjacent support block 2199.Upon correctly positioning the support blocks 2199, filler material2095, as shown in FIG. 20, may be introduced into, and the guide wiresmay be removed from, the cavities. In one embodiment, once positioned,the support blocks 2199 may generally comprise a cruciform shape, asshown in FIG. 21B.

In now looking at FIG. 22, with reference to FIGS. 1A & 2A, shown is amethod of reinforcing a femoral neck 102. The method starts at 2200. At2205, a bore is created proximate to at least one of a Ward's triangleand a greater trochanter 206. The at least one bore may be created witha drill such as, but not limited to, a coring drill, or other devicesuch as, but not limited to, a chisel or pick, and used to access thecancellous bone 108 within the femoral neck 202. At 2210 a compressedfemoral neck support structure 110 (as shown in FIG. 1B) is placedproximate the at least one of a Ward's triangle bore 120′ and greatertrochanter bore 120″. Correct placement of the device may occur throughthe use of an actuation device 340, as shown in FIG. 3A. Specifically, asteerable actuation device 340 may be used. At 2215, at least one cavityis created in a femoral neck cancellous bone 108. However, the at leastone cavity may also be created in a greater trochanter 206 and/or afemoral head 208 cancellous bone area. The at least one cavity may becreated by expanding a balloon 114 and compressing a portion of thefemoral neck cancellous bone 108. The balloon 114 may also be placed inthe correct position by the actuation device 340. At 2220, the femoralneck support structure 110 may be expanded. Expansion in one method mayoccur through expansion of the balloon 114. In order to reinforce thefemoral neck 102, when a load is placed on the femoral neck, as shown at2225, at least a portion of the load is subsequently transferred fromthe femoral neck bone to the femoral neck support structure 110, asshown at 2230.

Additional methods may include variations of the described steps aboveand may include further steps such as coupling the support structure tohealthy bone material. For example, the support structure may be coupledto healthy cortical bone or structurally active compressed cancellousbone using bone cement, clips, or staples. Other methods of coupling thesupport structure to healthy cortical bone may include through frictionbetween the device and the bone or compression force between the deviceand bone. Filler material may be introduced into the cavity. At least aportion of the load applied to the femoral neck may then be transferredthe support structure and the filler component. Finally, it iscontemplated that a fluid may be introduced into the cavity. However, afluid introduced to the cavity would likely be contained and enclosed bya fluid containment structure such as, but not limited to, a balloon.

Some of these steps, and others, are shown in FIG. 23. In oneembodiment, the start of the method of FIG. 23, at 2300, begins at theend of the method of FIG. 22. The additional steps include, at 2240,inserting one or more guide wires into the cancellous bone area. Thismay involve inserting a polymeric or 316L stainless steel wire into acavity created in the cancellous bone of the femoral neck. Once thewires are in position, the method continues at 2245, where one or moresupport blocks are sent along the wire into the cancellous bone area.Upon reaching the correct position, the one or more support blocks maybe positioned in a position adapted to support the femoral neck at 2250.Although one support position may be a generally cruciform position, asshown in FIG. 21B, other support block positions are also contemplated.Filler material is placed into at least one cavity at 2255, the fillermaterial adapting to form to the shape of the at least one cavity andsubsequently harden. Finally, at 2260, a portion of the load istransferred to the filler material, in addition to a portion of the loadbeing transferred to the support structure at 2230.

Referring to FIG. 24, shown is another method for reinforcing a femoralneck where in one embodiment the start of the method of FIG. 24, at2400, begins at the end of the method of FIG. 22. At 2465 the femoralneck support structure is enclosed with a sheath. This may compriseenclosing a compressed support structure such as, but not limited to,the compressed support structure shown in FIG. 1B. At 2470 the sheath isremoved and at 2475, the femoral neck support structure is expanded. Forexample, the sheath may be adapted to keep the support structure in acompressed position and upon removal the support structure may beadapted to expand. Finally, at 2480, a substantially rigid supportstructure is placed proximate at least one of a healthy femoral neckcortical bone, a compressed cancellous bone, or bone cement placedwithin the femoral neck. In one embodiment, the substantially rigidsupport structure is created upon removal of the sheath and expansion ofthe structure. In another embodiment, expansion of a support structuremay also occur through one of twisting, pulling, and pushing anactuation device.

Those skilled in the art can readily recognize that numerous variationsand substitutions may be made in the invention, its use and itsconfiguration to achieve substantially the same results as achieved bythe embodiments described herein. Accordingly, there is no intention tolimit the invention to the disclosed exemplary forms. Many variations,modifications and alternative constructions fall within the scope andspirit of the disclosed invention.

What is claimed is:
 1. A device for reinforcing a femoral neck bone, thefemoral neck bone including a cortical bone region and a cancellous boneregion, the device comprising: a unitary support structure deployablefrom a first substantially collapsed position to a second substantiallyexpanded position, the unitary support structure having an outer surfaceand including, a head portion, a distal neck portion, a proximal neckportion, and a rigid fastener disposed on the outer surface of theunitary support structure that physically couples with at least aportion of the internal cortical bone region when the support structureis deployed in the second substantially expanded position; the unitarysupport structure having a generally hourglass-shape when deployed inthe second substantially expanded position, the general hourglass-shaperesembling a cortical bone inner surface shape—wherein the supportstructure is adapted to displace at least a portion of the cancellousbone region and support the femoral neck bone, the displaced cancellousbone region forming a void within the femoral neck bone; the unitarysupport structure formed at least partially from a material thatincreases its rigidity after a period of time and further secures theunitary support structure in the void within the femoral neck; thedevice further including an actuator adapted to create a bore at theWard's triangle; create at least one cavity in a cancellous bone regionof the femoral neck; insert the unitary support structure through thebore at the Ward's triangle and into the at least one cavity; expand thesupport structure; and allow at least a portion of the load from thefemoral neck bone to be transferred to the unitary support structure,wherein the unitary support structure further comprises, an inflatablemember adapted to expand the unitary support structure from the firstsubstantially collapsed position to the second substantially expandedposition, wherein the unitary support structure comprises a stent, thestent including at least one or more compression springs.
 2. The deviceof claim 1 further comprising a sheath substantially retaining theunitary support structure in its first substantially collapsed positionwherein the unitary support structure is adapted to be extracted fromthe sheath and bi-directionally expand into the second substantiallyexpanded position along a plurality of axes.
 3. The device of claim 1,wherein, the unitary support structure is comprised of at least one of aviscoelastic material; a material having at least one of a time and atemperature dependent property; a gelatinous material; and a bone growthchemical regulator.
 4. The device of claim 1, wherein, the unitarysupport structure includes a longitudinal axis, at least a portion ofthe support structure may be adapted to receive a filler material, andthe filler material and support structure are adapted to support a firstload substantially perpendicular to the longitudinal axis between about1 N and about 12 kN and a second load substantially parallel to thelongitudinal axis between about 1 N and about 7 kN.
 5. The device ofclaim 1 wherein, the periphery of the unitary support structure isfurther adapted to interact with at least a portion of the cortical boneregion through friction.
 6. A device for reinforcing a femoral neckbone, the femoral neck bone including a cortical bone region and acancellous bone region, the device comprising: a unitary supportstructure deployable from a first substantially collapsed position to asecond substantially expanded position, the unitary support structurehaving an outer surface and including, a head portion, a distal neckportion, a proximal neck portion, and at least one staple disposed onthe outer surface of the unitary support structure that physicallycouples with at least a portion of the internal cortical bone regionwhen the support structure is deployed in the second substantiallyexpanded position; the unitary support structure having a generallyhourglass-shape when deployed in the second substantially expandedposition, the general hourglass-shape resembling a cortical bone innersurface shape—wherein the support structure is adapted to displace atleast a portion of the cancellous bone region and support the femoralneck bone; the displaced cancellous bone region forming a void withinthe femoral neck bone; the unitary support structure formed at leastpartially from a material that increases its rigidity after a period oftime and further secures the unitary support structure in the voidwithin the femoral neck, wherein the unitary support structure furthercomprises, an inflatable member adapted to expand the unitary supportstructure from the first substantially collapsed position to the secondsubstantially expanded position, wherein the unitary support structurecomprises a stent, the stent including at least one or more compressionsprings.